- Wholly owned product candidates - advancing, with expanding news flow expected.
Kadcyla® sales growing - launches in
- Beyond Kadcyla - encouraging initial clinical findings now reported with six other compounds in development through partnerships.
- Company updates guidance - expects to end fiscal year with greater cash balance than previously projected.
"The expanding amount of encouraging clinical data being reported by us
and our partners reflects the investments we have made in our technology
and in our product development capabilities," commented
ImmunoGen Wholly Owned Product Candidates
IMGN853 - This ADC is a potential treatment for folate receptor α-positive cancers, including many ovarian, endometrial and lung cancers.
Initial findings reported at the annual meeting of the
American Association of Cancer Research(AACR) earlier this month showed the change made in dose calculation - from use of total body weight (TBW) to adjusted ideal body weight (AIBW) - appears to have achieved its objective: none of the six patients treated with IMGN853 at 5 mg/kg AIBW had ocular toxicity compared with four of ten using TBW. Evidence of activity has been seen with IMGN853 at doses of 3.3 mg/kg (TBW) and above, as previously reported.
Additional IMGN853 clinical data are to be presented at the upcoming
annual meeting of the
American Society of Clinical Oncology(ASCO).
- The Company expects to establish the maximum tolerated dose of IMGN853 with the current once every 3 weeks dosing schedule this quarter and to begin assessing IMGN853 specifically in patients with platinum-resistant ovarian cancer or relapsed endometrial cancer. The first disease-specific data are expected to be reported later this year.
- IMGN853 also is being assessed using a modified weekly dosing schedule, to enable the best schedule to be used as it advances.
IMGN529 - This CD37-targeting ADC is a potential new treatment for B-cell malignancies, including non-Hodgkin lymphoma.
- The first clinical findings with IMGN529 are scheduled for presentation at ASCO.
IMGN289 - This EGFR-targeting ADC is a potential new treatment for many epithelial tumors, including squamous cell head/neck and lung cancers.
- The Company reported preclinical data at AACR on the activity of IMGN289 against tyrosine kinase inhibitor (TKI)-resistant EGFR-positive cancers.
- Dose-escalation is ongoing in the IMGN289 Phase I clinical trial, with updates - initial data and/or development events - expected in the second half of 2014.
Roche's Kadcyla (ado-trastuzumab emtansine) is the first marketed product utilizing ImmunoGen's ADC technology.
Sales - Roche reported global Kadcyla sales of
102 million CHF(approximately $115 million) for the first quarter of 2014 (January-March, 2014). Launch of Kadcyla has begun in some countries in the EU and is ongoing in the US; launch in Japanbegan last week. ImmunoGen receives and recognizes royalties on Kadcyla sales in the quarter after the quarter in which Roche records the sales.
- First-line for HER2-positive metastatic breast cancer - Roche expects results from its MARIANNE Phase III trial to be reported in the second half of 2014, and - with positive results - to submit in 2015 for regulatory approval.
- Advanced HER2-positive gastric cancer - Roche is evaluating Kadcyla for second-line use in this disease in its GATSBY trial. Regulatory submission - with positive results - is expected in 2015.
- Early stage HER2-positive breast cancer - Roche has three Phase III trials with Kadcyla: KAITLIN, for adjuvant use, which is underway; KATHERINE, for residual invasive disease, which is underway; and KRISTINE, for neo-adjuvant use, which is expected to start this quarter.
A number of leading companies in oncology are developing anticancer compounds through partnerships with ImmunoGen. Recent updates include:
- The first clinical data with Amgen's AMG 595 in glioblastoma were reported at AACR, with evidence of activity seen at doses that were well tolerated.
With the presentation of the AMG 595 data at AACR, encouraging initial
clinical findings have now been reported for six partner compounds in
addition to Kadcyla: Amgen's AMG 595, Bayer HealthCare's BAY 94-9343
(anetumab ravtansine), Biotest's BT-062 (indatuximab ravtansine),
SAR3419(coltuximab ravtansine), SAR566658, and SAR650984.
- Patient dosing has begun in a clinical trial assessing CD138-targeting BT-062 for the treatment of triple negative metastatic breast cancer and metastatic urinary bladder cancer. BT-062 also is in clinical testing for the treatment of multiple myeloma. ImmunoGen has a BT-062 opt-in right for co-development and co-commercialization jointly with Biotest in the US.
- ImmunoGen expects one or more partner IND submissions in 2014, plus additional clinical data presentations.
For the Company's quarter ended
Revenues for 3Q FY2014 were
Revenues in 3Q FY2014 also include
Operating expenses in 3Q FY2014 were
ImmunoGen had approximately
Updated Financial Guidance for Fiscal Year 2014
ImmunoGen is updating its financial guidance for FY2014 from that issued
Revenues to be between $60 million and
$64 million, compared with previous guidance of between $71 million and $75 million;
Operating expenses to be between
$133 millionand $137 million, compared with previous guidance of between $140 millionand $144 million;
Net loss to be between $71 million and
$75 million, compared with previous guidance of between $67 million and $71 million;
Net cash used in operations to be between
$56 millionand $60 million, compared with previous guidance of between $64 millionand $68 million;
Capital expenditures to between
$8 millionand $10 million, unchanged from previous guidance; and
To end its fiscal year on
June 30, 2014with cash and cash equivalents of between $134 million and $138 million, compared with previous guidance of between $124 million and $128 million.
"We are investing in advancing and expanding our portfolio of compounds
designed to make a meaningful difference for patients with cancer,"
Conference Call Information
ImmunoGen is holding a conference call today at
Kadcyla® is a registered trademark of
This press release includes forward-looking statements based on
management's current expectations. These statements include, but are not
limited to, ImmunoGen's expectations related to: the Company's revenues,
operating expenses, net loss, cash used in operations and capital
expenditures in its 2014 fiscal year; its cash and marketable securities
|SELECTED FINANCIAL INFORMATION|
|(in thousands, except per share amounts)|
|CONDENSED CONSOLIDATED BALANCE SHEETS|
|Cash and cash equivalents||$||164,076||$||194,960|
|LIABILITIES AND SHAREHOLDERS' EQUITY|
|Long-term portion of deferred revenue and other long-term liabilities||67,563||72,576|
|Total liabilities and shareholders' equity||$||186,694||$||213,596|
|CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS|
|Three Months Ended||Nine Months Ended|
|License and milestone fees||$||305||$||22,010||$||39,150||$||23,372|
|Research and development support||1,948||2,257||5,860||5,670|
|Clinical materials revenue||2,064||734||2,197||2,662|
|Research and development||38,280||21,318||81,171||66,674|
|General and administrative||6,040||4,995||18,013||16,098|
|Total operating expenses||44,320||26,313||99,184||82,772|
|Loss from operations||(37,445)||(1,312)||(45,031)||(51,068)|
|Other (expense) income, net||(7)||(39)||166||132|
|Net loss per common share, basic and diluted||$||(0.44)||$||(0.02)||$||(0.53)||$||(0.61)|
|Weighted average common shares outstanding, basic and diluted||85,684||84,279||85,375||83,923|
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